Medical device makers and importers can face penalty of up to Rs 1 crore if products sold in India are found to be unsafe or if they fail to protect personal health information of patients, according to the draft bill proposed by NITI Aayog.
The draft Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 – circulated within ministries by NITI Aayog – also proposes to create a National Register of Medical Devices, a unique identification number (UID) to be displayed on the label of a product in a prescribed format, provisions for compensation for harm or injury and a separate regulator or Medical Device Administration to oversee the sector.
TOI has reviewed the draft bill intended to make sale and use of medical devices safer and sources said there is a broad consensus on the proposed law that is likely to be put up for public comments soon.
Apart from the Rs 1 crore fine for violation of safety, conditions of conformity and failure to protect personal health information of patients, the draft bill also has stringent penalty provisions, including imprisonment for offences related to sale of medical devices, clinical trials and fraud. As per the proposed provisions, all medical devices will have to be registered in the NRMD before they enter the market.
For existing products, it suggests registration within 12 months after the new law coming into force. Medical device manufacturers and importers will have to comply with conformity assessment requirements specified by the regulator on the basis of standards framed by the Bureau of Indian Standards.
Companies will also have to submit clinical data to seek approvals for their products. The draft also mandates companies to do post-marketing surveillance and report adverse events related to devices.
The Aayog has proposed that the Medical Devices Administration should have powers to conduct audits, give approvals as well search and seizure. The administration may refuse approval to devices that have resulted in adverse events, were recalled or declared unsafe in any other country, according to the draft bill.
As per draft, the administration will consist of a chairperson, four whole-time members, six ex-officio members and an ex-officio member-secretary.
“Undoubtedly a new regulatory agency with specialised expertise in medical devices would be a welcome move. The Central Drugs and Standard Control Organisation lacks the requisite technical competence and has not been up to the mark in regulating the limited devices currently notified as drugs,” says Malini Aisola of All India Drug Action Network.- News Rain